TIDMAZN
RNS Number : 8817B
AstraZeneca PLC
25 September 2018
25 September 2018 13:15 BST
Imfinzi is the first immunotherapy to demonstrate
significant
overall survival benefit in unresectable, Stage III lung
cancer
Imfinzi reduced the risk of death by nearly one third
compared to standard of care in the Phase III PACIFIC trial
Updated data reaffirm unprecedented improvement
in progression-free survival of more than 11 months
AstraZeneca and MedImmune, its global biologics research and
development arm, have presented data on overall survival (OS) in
the Phase III PACIFIC trial of Imfinzi during the Presidential
Symposium of the IASLC 19th World Conference on Lung Cancer hosted
by the International Association for the Study of Lung Cancer in
Toronto, Canada.
Results from the Phase III PACIFIC trial were published
simultaneously in the New England Journal of Medicine, showing
Imfinzi (durvalumab) significantly improved OS, the second primary
endpoint of the trial, compared to standard of care regardless of
PD-L1 expression, reducing the risk of death by 32% (HR 0.68,
99.73% CI 0.47-0.997; p=0.0025).
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer, said: "These data establish
Imfinzi as the first immunotherapy to demonstrate an overall
survival benefit for patients with unresectable, Stage III
non-small cell lung cancer following chemoradiation therapy.
Today's announcement brings new hope to patients in a setting where
survival rates have not changed in decades."
Scott J. Antonia, MD, Ph.D., chair of the Thoracic Oncology
Department at Moffitt Cancer Center in Tampa, Florida, USA and
principal investigator in the PACIFIC trial said: "The five-year
survival rate in this setting has historically been around 15%
after concurrent chemoradiation therapy. The significant survival
benefit observed using the PACIFIC regimen provides confidence and
clear rationale for a new standard of care."
Summary of primary endpoints
Imfinzi Placebo
(n=476) (n=237)
OS (primary endpoint)(1)
==========================
Number of deaths (%) 183 (38.4%) 116 (48.9%)
============= ===========
Hazard ratio 0.68 (0.47, 0.997)
(99.73% CI)(2,3)
==========================
p-value(2-4) 0.0025
==========================
Median in months NR(5) 28.7
(95% CI) (34.7, NR) (22.9, NR)
============= ===========
PFS (primary endpoint)(1,6)
==========================
Number (%) of patients with event 243 (51.1%) 173 (73.0%)
============= ===========
Hazard ratio 0.51 (0.41, 0.63)
(95% CI)(2,7)
==========================
Median in months 17.2 5.6
(95% CI) (13.1, 23.9) (4.6, 7.7)
============= ===========
(1) The data cut-off date for analysis of OS and updated
analysis of PFS was 22 March 2018.
(2) Stratified by sex, age, and smoking history.
(3) Confidence interval adjusted for interim analysis.
(4) Criteria for statistical significance at the interim
analysis of OS was a p-value <= 0.00274 (using Lan DeMets
spending function approximating O'Brien Fleming boundary).
(5) Not Reached (NR).
(6) Assessed by Blinded Independent Central Review (BICR)
according to RECIST v1.1.
(7) No formal statistical comparison was made because the study
had achieved significance for PFS at the first planned interim
analysis (data cutoff of Feb 13, 2017).
The safety and tolerability profile for Imfinzi was consistent
with that reported at the time of the progression-free survival
(PFS) analysis. Among patients receiving Imfinzi, the most common
adverse reactions (greater than or equal to 20% of patients) versus
placebo were cough (35.2% vs. 25.2%), fatigue (24.0% vs. 20.5%),
dyspnea (22.3% vs. 23.9%) and radiation pneumonitis (20.2% vs.
15.8%). 30.5% of patients experienced a grade 3 or 4 AE with
Imfinzi vs 26.1% with placebo, and 15.4% of patients discontinued
treatment due to AEs with Imfinzi vs. 9.8% of patients on
placebo.
Imfinzi is currently approved in the US, EU, Canada,
Switzerland, India, Japan and Brazil based on the PACIFIC trial.
Other global health authority reviews and submissions are
ongoing.
About Stage III NSCLC
Stage III (locally-advanced) NSCLC is commonly divided into
three sub-categories (IIIA, IIIB and IIIC), defined by how much the
cancer has spread locally and the possibility of surgery. Stage III
disease is different from Stage IV disease, when the cancer has
spread (metastasised) to distant organs, as Stage III is currently
treated with curative intent.
Stage III NSCLC represents approximately one-third of NSCLC
incidence and was estimated to affect around 105,000 patients in
the top-eight countries (China, France, Germany, Italy, Japan,
Spain, UK, US) in 2017. The majority of Stage III NSCLC patients
are diagnosed with unresectable tumours. No new treatments beyond
chemoradiation therapy, followed by active surveillance to monitor
for progression, have been available to patients for decades.
About PACIFIC
The PACIFIC trial is a Phase III, randomised, double-blinded,
placebo-controlled, multi-centre trial of Imfinzi as treatment in
'all-comer' patients (i.e. regardless of PD-L1 status) with
unresectable, Stage III (locally-advanced) NSCLC whose disease has
not progressed following platinum-based chemotherapy and radiation
therapy (CRT).
The trial is being conducted in 235 centres across 26 countries
involving 713 patients. The primary endpoints of the trial are PFS
and OS, and secondary endpoints include landmark PFS and OS,
objective response rate, and duration of response.
About Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds
to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80,
countering the tumour's immune-evading tactics and releasing the
inhibition of immune responses.
Imfinzi is approved for unresectable, Stage III NSCLC in the US,
EU, Canada, Switzerland, India, Japan, and Brazil based on the
Phase III PACIFIC trial. Imfinzi is also approved for the treatment
of patients with locally-advanced or metastatic urothelial
carcinoma in the US, Canada, Brazil, Israel, Hong Kong, and
India.
As part of a broad development programme, Imfinzi is also being
tested as a monotherapy and in combination with chemotherapy,
radiation therapy, small molecules, and tremelimumab, an anti-CTLA4
monoclonal antibody, as a first or second-line treatment for
patients with NSCLC, small cell lung cancer, locally-advanced or
metastatic urothelial carcinoma, head and neck cancer and other
solid tumours.
About AstraZeneca in Lung Cancer
Lung cancer is the leading cause of cancer death among both men
and women, accounting for about one-third of all cancer deaths.
AstraZeneca has a comprehensive portfolio of approved and
potential new medicines in late-stage clinical development for the
treatment of different forms of lung cancer across all stages of
disease and lines of therapy. We aim to address the unmet needs of
patients with EGFR-mutated tumours as a genetic driver of disease,
which occur in 10-15% of NSCLC patients in the US and EU and 30-40%
of NSCLC patients in Asia, with our approved medicines Iressa and
Tagrisso and ongoing FLAURA, ADAURA and LAURA Phase III trials. Our
extensive late-stage immuno-oncology programme focuses on 75-80% of
patients with lung cancer without a known genetic mutation.
Imfinzi, an anti-PDL1 antibody is in development as monotherapy
(ADJUVANT BR.31, PACIFIC2, MYSTIC and PEARL Phase III trials) and
in combination with tremelimumab and/or chemotherapy (MYSTIC,
NEPTUNE, POSEIDON and CASPIAN Phase III trials).
About AstraZeneca's Approach to Immuno-Oncology (IO)
Immuno-Oncology (IO) is a therapeutic approach designed to
stimulate the body's immune system to attack tumours. At
AstraZeneca and MedImmune, our biologics research and development
arm, our IO portfolio is anchored by immunotherapies that have been
designed to overcome anti-tumour immune suppression. We believe
that IO-based therapies will offer the potential for life-changing
cancer treatments for the clear majority of patients.
We are pursuing a comprehensive clinical trial programme that
includes Imfinzi (anti-PDL1) as monotherapy and in combination with
tremelimumab (anti-CTLA4) in multiple tumour types, stages of
disease, and lines of therapy, using the PD-L1 biomarker as a
decision-making tool to define the best potential treatment path
for a patient. In addition, the ability to combine our IO portfolio
with small, targeted molecules from across our Oncology pipeline,
and with those of our research partners, may provide new treatment
options across a broad range of tumours.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a
quickly-growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, we
are committed to advancing Oncology as a growth driver for
AstraZeneca, focused on lung, ovarian, breast and blood cancers. In
addition to our core capabilities, we actively pursue innovative
partnerships and investments that accelerate the delivery of our
strategy as illustrated by our investment in Acerta Pharma in
haematology.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and, one day, eliminate cancer as a cause
of death.
About MedImmune
MedImmune is the global biologics research and development arm
of AstraZeneca, a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of small-molecule and biologic prescription
medicines. MedImmune is pioneering innovative research and
exploring novel pathways across Oncology; Respiratory;
Cardiovascular, Renal & Metabolic Diseases; and Infection and
Vaccines. The MedImmune headquarters is located in Gaithersburg,
MD, one of AstraZeneca's three global R&D centres, with
additional sites in Cambridge, UK, and Mountain View, CA. For more
information, please visit www.medimmune.com.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide.
For more information, please visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
CONTACTS
Media Relations
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Gonzalo Viña UK/Global +44 203 749 5916
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Henry Wheeler Oncology +44 203 749 5797
Christer Gruvris Cardiovascular; Metabolism +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
Josie Afolabi Other +44 203 749 5631
Craig Marks Finance; Fixed Income +44 7881 615 764
Jennifer Kretzmann Retail Investors +44 203 749 5824
Adrian Kemp
Company Secretary
AstraZeneca PLC
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END
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